BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMYL GEN.2

    MDR report key: 21209351 · Received January 22, 2025

    Report

    Report Number
    1823260-2025-00198
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    December 17, 2024
    Report Date
    February 27, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFJ
    UDI-DI
    04015630918935
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GENERAL REAGENT PROBLEM CAN BE EXCLUDED BECAUSE CALIBRATION AND QC WERE ACCEPTABLE. BASED ON THE HIGH AMOUNT OF SAMPLE-RELATED ALARMS AND THE FACT THAT THE PRE-ANALYTICS WERE NOT HANDLED ACCORDING TO THE TUBE INSTRUCTION FOR USE (TARGET VOLUME VS DRAW VOLUME AND AN INCORRECT CENTRIFUGATION SPEED), THE CAUSE OF THE EVENT WAS CONSISTENT WITH A PREANALYTIC ISSUE AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE COBAS C502 MODULE SERIAL NUMBER WAS (B)(6). QC WAS WITHIN THE RANGES. THE ALARM TRACE PROVIDED FROM (B)(6) 2024 SHOWED ABNORMAL SAMPLE ASPIRATION ALARMS 66 TIMES AND ABNORMAL CELL BLANK ALARMS 31 TIMES. THE CUSTOMER EXCHANGED THE PHOTOMETER LAMP AND CUVETTES REGULARLY ACCORDING TO SPECIFICATIONS AND CLEANED THE SAMPLE AND REAGENT NEEDLES DAILY. THE GEAR PUMP HAD NOT BEEN REPLACED AND THE FIELD SERVICE ENGINEER CONFIRMED THAT THE GEAR PUMP PRESSURE MORE THAN 300KPA. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLES NOT MATCHING THE PATIENT'S CLINICAL DIAGNOSIS WHEN TESTED WITH AMYL GEN.2 (AMYL2) ASSAY AND LIPASE COLORIMETRIC ASSAY (LIPC) ASSAY ON A COBAS 8000 COBAS C502 MODULE. THIS MEDWATCH WILL APPLY TO THE AMYL2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE LIPC ASSAY. ON (B)(6) 2024, THE 1ST SAMPLE (SERUM/PLASMA SAMPLE) WAS TESTED RESULTING IN: AMYL2 RESULT: 576 U/L. LIPC RESULT: 1692.5 U/L. ON (B)(6) 2024, THE PHYSICIAN REQUESTED A 2ND SAMPLE TO BE DRAWN AND TESTED RESULTING IN: AMYL2 RESULT: 338 U/L (URINE SAMPLE). AMYL2 RESULT: 104 U/L (SERUM SAMPLE). LIPC RESULT: 47.8 U/L (SERUM SAMPLE). ON (B)(6) 2024, THE PHYSICIANS QUESTIONED THE RESULTS AND REQUESTED A 3RD BLOOD SAMPLE TO BE DRAWN AND TESTED RESULTING IN: AMYL2 RESULT: 195 U/L. LIPC RESULT: 259.3 U/L. ON (B)(6) 2024, THE ORIGINAL SAMPLE WAS REPEATED RESULTING IN: AMYL2 RESULT: 577 U/L. LIPC RESULT: 1644.4 U/L. THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND EXPECTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843568 AMYL GEN.2 LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES JFJ ROCHE DIAGNOSTICS 79988201 04015630918935

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male LONG-TERM ASPIRIN| PANTOPRAZOLE| RACEANISODAMINE| ROSUVASTATIN